QA Specialist

Company Description

Entrusted by Pfizer Singapore, Cielo Talent supports Pfizer to recruit permanent employees for the expansion of Pfizer Tuas manufacturing site in Singapore.

**Why Pfizer**

Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.

**Why Patients Need You**

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

**Job Description**:
**Position Summary**

The incumbent is a member of the Quality Assurance team. Under the supervision of the Senior Compliance Manager, the incumbent will be responsible for the following:

- Management of site Standard Operating Procedures (SOPs) and documentation systems (including controlled copiesmanagement, document archival and retrieval) in accordance to Pfizer Quality Standards (PQS) and ALCOA principles.
- Drive quality culture and promote GMP compliant behaviours at the site.
- Support improvement of quality systems in collaboration with cross functional teams.
- Contribute to achieve our vision of being best in class manufacturing site, producing highest quality products in the safest way.

**Position Responsibilities And Job Related Requirements**

**Responsibilities**:

- Author SOPs and associated GMP documentation related to site SOP management and documentation systems in accordance to PQS and ALCOA principles.
- Provide QA oversight of archival activities of hard copy GMP records into site archives and/or off-site facilities throughout required retention period to eventual records disposal, ensuring compliance with site SOPs.
- Manage control and issuance of GMP controlled documentation.
- Review and approve site documents (e.g. SOPs, forms) as document controller, ensuring adherence to site SOPs.
- Handle duties related to DPOC (Designated Point of Contact) and super user for PDOCs system (e.g. configuration changes, user administration and periodic reviews).
- Lead or support investigations related to documentation systems, as required.
- Implement improvements to site SOP management and documentation systems, as necessary.
- Maintain inspection readiness and provide documentation support for internal and external GMP inspections.
- Actively participate in GMP walk downs to ensure documentation systems are maintained in inspection ready state and adhere to site procedures.
- Participate in gap analysis of site procedures against PQS and propose required actions to address identified gaps and mitigate risks.
- Maintain current quality tracking systems and quality metrics to proactively identify trends and atypical observations.
- Uphold Pfizer's code of conduct and values.
- Play an active and impactful role in Tier processes by updating performance against metrics, highlighting & resolving issues, with appropriate escalations.
- Collaborate with cross-functional teams to drive flawless execution.
- Actively participate in Safety initiatives, and perform investigation related to EHS (as needed).

**Qualifications**:
**Key Requirements**:

- Degree in Science/ Chemical Engineering or equivalent with 1 year of related experiences or Diploma in Pharmaceutical/ Chemical Engineering or equivalent with 3 years of related experiences.
- Pior experiences in GMP document control roles preferred.

Additional Information

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.